Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients

Sponsor

Fundacion Rioja Salud (Other)

Overall Status

Suspended

CT.gov ID

NCT02038998

Collaborator

Hospital San Pedro (Other)

Enrollment

Location

Arms

173

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Stroke is one of the leading causes of death and disability worldwide. More than 85% of strokes are due to blood vessel occlusion resulting in partial destruction of the brain parenchyma. Current protocols try to re-establish blood circulation as soon as possible through chemical and/or mechanical interventions but new strategies are needed.

Periodic acceleration (pGz) is a non-invasive method consisting in the application of a rocking movement to the patient that ultimately will induce the release of beneficial chemicals from the vascular endothelium (the cells lining the inside of the blood vessels). Application of pGz in an animal model of stroke resulted in a dramatic reduction of associated brain damage.

This trial will investigate whether stroke patients exposed to pGz experiment significantly higher recovery than patients that remained static during their treatment.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Stroke	Device: Exer-Rest® TL	N/A

Detailed Description

This trial will investigate whether stroke patients exposed to pGz experiment significantly higher recovery than patients that remained static during their treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Unicentric, Phase II, Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients

Actual Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

May 1, 2028

Anticipated Study Completion Date :

Jun 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Static group Control group. They will receive the standard care provided by the protocols of the ictus unit. They will lay on the Exer-Rest® TL device but the acceleration will NOT be connected.	Device: Exer-Rest® TL Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.
Experimental: Single pGz intervention In addition to the standard care established in the ictus unit, these patients will receive a single exposure to pGz on the Exer-Rest® TL, for 3 hours, during the first day of their stay in the hospital.	Device: Exer-Rest® TL Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.
Experimental: Multiple pGz interventions In addition to the standard care, these patients will be exposed to 45 minutes of pGz, on the Exer-Rest® TL, every day during their first week in the Hospital.	Device: Exer-Rest® TL Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.

Arm

Intervention/Treatment

Sham Comparator: Static group

Control group. They will receive the standard care provided by the protocols of the ictus unit. They will lay on the Exer-Rest® TL device but the acceleration will NOT be connected.

Device: Exer-Rest® TL

Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.

Experimental: Single pGz intervention

In addition to the standard care established in the ictus unit, these patients will receive a single exposure to pGz on the Exer-Rest® TL, for 3 hours, during the first day of their stay in the hospital.

Device: Exer-Rest® TL

Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.

Experimental: Multiple pGz interventions

In addition to the standard care, these patients will be exposed to 45 minutes of pGz, on the Exer-Rest® TL, every day during their first week in the Hospital.

Device: Exer-Rest® TL

Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.

Outcome Measures

Primary Outcome Measures

NIHSS and Rankin scales [0hr, 2hr, 24hr, 48hr, 7ds, 90ds]
The NIHSS and Rankin scales will be applied to the patients at the indicated times

Secondary Outcome Measures

Infarct volume [7 days]
Infarct volume will be measured by nuclear magnetic resonance 7 days after stroke

Other Outcome Measures

Blood markers [0, 1, 3, 5, and 7ds]
Neuroprotective substances that can be released by pGz (nitric oxide, tissue plasminogen activator, adrenomedullin, prostaglandins, etc) will be measured in the blood of patients to investigate the efficacy of the treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A signed informed consent form must be obtained prior to recruitment
Patients with symptoms of acute ischemic stroke
Less than 12 hours from initiation of the stroke
Age: 18 years or older
Capable of following the protocol

Exclusion Criteria:

Pregnant or lactating women, and women that do not follow a contraceptive plan and may become pregnant
Less than 18 years of age
More than 12 hours from the initiation of the stroke or when the initiation time is unknown.
Hemorrhagic stroke
Candidates to receive thrombolytic treatment
Spine traumatism or other conditions that may be aggravated by pGz
Patients that cannot be properly followed because of phycological, social, familiar, or geographical reasons.